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The pharmaceutical company Janssen, who produce a range of myeloma medicines, have today announced their application to the European Medicines Agency (EMA) for a license extension for daratumumab. This license extension, if approved by the EMA, would allow the use of subcutaneous (under the skin) daratumumab (Darzalex®) in myeloma patients.

Daratumumab is a monoclonal antibody, which works by targeting CD38, which is expressed on myeloma cells. It is currently administered through an intravenous (IV – through the vein) drip in patients and is licenced by the EMA in the following settings:

  • As a monotherapy (on its own) for heavily pre-treated myeloma patients
  • In combination with bortezomib and dexamethasone for relapsed myeloma patients
  • In combination with lenalidomide and dexamethasone for relapsed myeloma patients
  • In com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant

The license extension would apply to all currently approved settings of daratumumab, allowing daratumumab to be administered intravenously or subcutaneously.

The EMA sub­mission is sup­ported by two studies, the Phase 2 PLEIADES (MMY2040) study and the Phase 3 COLUMBA (MMY3012) study. Both studies found that subcutaneous daratumumab had comparative effectiveness to IV daratumumab. In the subcutaneous arm, infusion times were quicker for patients and they also found a lesser incidence of “infusion-related reaction”, a common side-effect of daratumumab during the first infusion.

You can see the full Janssen press release here.

Myeloma Patients Europe will be following the progress of the license extension application over the coming weeks. In the meantime, if you have any questions or comments, please email Kate Morgan at morgan@mpeurope.org

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